This invention relates to a balloon catheter, particularly in the form of an endotracheal catheter, with a catheter tube of elastic, tissue-compatible material, e.g., in the form of a respirator hose with a bevelled, open distal end and an open proximal end, and a connector, which is connected tightly with the catheter tube. The connector is optionally detachable.
Balloon catheters wherein a retention sleeve and a signal balloon are mounted on the catheter tube and are connected with each other through one or more feed tubes and with connection fittings for inflation of the retention sleeve and signal balloon are known in the art. German Pat. No. DE-OS 26 25 570 discloses a catheter with a sleeve balloon with is inflatable through an inflation lumen (channel), which is connected through the inflation lumen with a safety or signal balloon. The principle of the construction and the method of operation of this catheter are shown in FIGS. 1-4 of this patent. Both a sleeve balloon, in the vicinity of the distal end of the tube, and also a signal or safety balloon in the vicinity of the proximal end, are located on the catheter tube. As is shown particularly in FIG. 4, the air flow is fed through the feed lines in such a manner that the sleeve near the distal end is inflated first and the signal balloon is filled only when the pressure in the sleeve is greater than the predetermined standard inflation pressure. The safety balloon then lies beyond the sleeve balloon in the direction of air flow. This provides the advantage that no higher pressure is used during the safety balloon inflation than that in the sleeve balloon. However, this construction is very costly to manufacture and thus cannot be used in practice.
A catheter with inflatable sleeve and signal balloon is described in U.S. Pat. No. 3,543,759. In FIG. 1 of this patent, both balloons are arranged on the catheter tube and are connected with each other through a lumen 16 through the apertures 17 and 18, and with the side arm 25 which leads to the outside. The sleeve and signal balloons shown in FIGS. 1, 3, 4 and 6 of this patent are arranged separately on the catheter tube and connected tightly with the tube. This type of construction is quite costly.
Balloon catheters, e.g. as disclosed in German Pat. Nos. DE-AS 15 91 793, DE-OS 19 25 852, DE-AS 22 46 526, DE-AS 24 26 344, DE-OS 28 03 094 and DE-PS 30 28 568, are frequently used in surgery. For hygenic reasons, particularly to avoid infection in the hospital, i.e., the so-called hospital infection, each patient is treated more and more frequently with disposable new, sterile instruments. Hospitals are increasingly being forced to provide and use balloon catheters as sterile instruments which are intended to be used only once.
However, until the present time, the customary types of structures of balloon catheters intended for only one use have been very costly. An endotracheal catheter of the most useful type of structure, for example, with a retention sleeve, is essentially composed of six different individual parts, including a respirator tube, a retention sleeve, a signal balloon, a ventilation tube as a connection between the sleeve and signal balloon, a connector and connection fittings with shoulders on the signal balloon for a retention injector. Other balloon catheters are constructed in a similar manner. The parts must be manufactured individually and then assembled and, if necessary, are connected tightly or permanently with each other. Their manufacture is therefore very time consuming and burdensome.
Therefore, a need exists for balloon catheters, particularly endotracheal catheters, which can be manufactured so that the manufacturing costs of such instruments, which are to be used only once, are commercially feasible.
Therefore, the object of the present invention is to provide balloon catheters, particularly endotracheal catheters which are characterized by considerably simpler and more advantageous construction than customary balloon catheters, with sleeves and signal balloons, which can be manufactured at low cost.